Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091001
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NISOLDIPINE | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
NISOLDIPINE | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
NISOLDIPINE | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
NISOLDIPINE | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/26/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091001s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/11/2022 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
NISOLDIPINE
TABLET, EXTENDED RELEASE;ORAL; 8.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NISOLDIPINE | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091001 | MYLAN |
SULAR | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020356 | COVIS |
TABLET, EXTENDED RELEASE;ORAL; 17MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NISOLDIPINE | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091001 | MYLAN |
SULAR | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020356 | COVIS |
TABLET, EXTENDED RELEASE;ORAL; 34MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NISOLDIPINE | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091001 | MYLAN |
SULAR | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020356 | COVIS |